Vivozon said that it has obtained good clinical results from the U.S. phase 2b study for Opiranserin, its nonnarcotic analgesics, in treating patients who had undergone a bunionectomy.
The company confirmed safety and tolerability for Opiranserin through six previous clinical trials. The treatment repeatedly demonstrated particularly good analgesic effects in pain severities of seven or more, which, in turn, led to reduced use of opioids.
"The phase 2b study was an exploratory trial to refine the trial design of phase 3 clinical trials with definitive results," Vivozon CEO Lee Doo-hyun said. "The company enrolled a total of 60 patients with the pain intensity of four grades or higher before administration."
As a result, significant pain reduction was observed within 30 minutes to one hour of the administration, Lee added.
According to Lee, in the U.S. FDA's proposed method of "pain detection patient percentage," about 70 percent of patients in the test group had significant differences from the placebo group as they pressed the pain- reduced button within 30 minutes.
"Such results demonstrate that the analgesic effects of Opiranserin appear at a similar rate to that of narcotic analgesics," Lee said.
However, the 12-hour pain margin area as the primary endpoint indicator did not reach statistical significance due to the small number of patients.
The pain margin area can be measured after calculating the intensity of pain felt by patients in each time zone of a graph of zero to 10.
"Our company plans to conduct an additional phase 3b clinical trial, participated in by 300 patients, and hopes to get a statistically significant result in the process," Lee said.
Despite certain shortcomings, Lee stressed that the drug still showed excellent efficacy in patients with severity of 7 or higher in pain intensity.
"After 30 minutes of administration, the pain intensity significantly decreased, showing a difference of 2 or more levels compared to the placebo group, and the efficacy continued until 24 hours," Lee said. "Also, a statistically significant result was obtained for the opioid reduction, and such data will be very helpful in designing and conducting the phase 3b clinical trial."
The company is also awaiting phase 3a clinical trial results for Opiranserin in treating abdominal plastic surgery this year and is targeting to launch the drug by 2022, he added.
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